New injectable antibody treatment for asthma

Cinqaero (reslizumab) can be prescribed as add-on therapy in adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids and another maintenance treatment.

Eosinophils play a key part in the promotion and maintenance of airway inflammation, airway wall thickening, fibrosis and angiogenesis. | SCIENCE PHOTO LIBRARY
Eosinophils play a key part in the promotion and maintenance of airway inflammation, airway wall thickening, fibrosis and angiogenesis. | SCIENCE PHOTO LIBRARY

Reslizumab is a humanised monoclonal antibody that binds specifically to interleukin-5 (IL-5), a major cytokine responsible for the differentiation, maturation, recruitment and activation of eosinophils. The biological function of IL-5 is blocked, thereby reducing the survival and activity of eosinophils.

Reduction in asthma exacerbations

Two duplicate double-blind, randomised controlled trials evaluated the safety and efficacy of reslizumab in 2597 patients with asthma inadequately controlled by medium to high doses of inhaled corticosteroids. Patients had blood eosinophil counts of ≥400 cells per µL plus one or more exacerbations in the previous year.

Patients were randomised to receive reslizumab 3mg/kg by iv infusion or placebo every four weeks for one year. The primary outcome measure was the annual frequency of clinical asthma exacerbations.

In a pooled analysis of both studies, the annual rate of asthma exacerbations in patients receiving reslizumab was reduced by 54% compared with those receiving placebo (rate ratio 0.46 [95% CI 0.37—0.58], p<0.0001).

Improvement in FEV1 was also significantly greater in patients receiving reslizumab than in those receiving placebo (0.23L and 0.22L vs 0.11L and 0.12L at 16 and 52 weeks, respectively [p < 0.0001 for both]).

Another phase III study evaluated the efficacy and safety of reslizumab 0.3mg/kg and 3mg/kg in 315 patients with asthma inadequately controlled by at least a medium-dose inhaled corticosteroid and eosinophils ≥400 cells per µL.

The change in FEV1 from baseline to 16 weeks was significantly greater with reslizumab than with placebo (difference: 0.3mg/kg, 115mL [95% CI 16—215]; p=0.0237; 3mg/kg, 160mL [95% CI 60259]; p=0.0018).

In all three studies reslizumab was superior to placebo in terms of patient-reported measures of asthma control and quality of life.

Administration

The recommended dose of reslizumab is 3mg/kg once every four weeks by iv infusion over 20 to 50 minutes. Treatment should be reviewed at least annually with regard to disease severity and level of exacerbation control.

Raised blood creatine phosphokinase was reported as the most frequently occurring adverse effect.


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